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OSHA Implements COVID-19 Emergency Temporary Standard for Healthcare and Updates COVID-19 Guidance for all Employers

On June 10, 2021, the Occupational Safety and Health Administration (“OSHA”) announced an action OSHA has not taken in 38 years: issuing an Emergency Temporary Standard (“ETS”).  This ETS aims to protect “healthcare and healthcare support service workers from occupational exposure to COVID-19 in settings where people with COVID-19 are reasonably expected to be present.”  The ETS does not go into effect until publication in the Federal Register, which has not yet occurred but appears imminent (OSHA has submitted the ETS to the Office of the Federal Register for publication and codification in 29 CFR 1910 Subpart U).  The text of the ETS, as submitted to the Office of the Federal Register, is available here.  OSHA also launched a website with resources regarding the ETS.

New California Medical Waste Law Impacts Out-of-State Manufacturers and Distributors with Costly Compliance Mandates

In late 2018, California passed a new law that will, in the near future, present sweeping changes to the pharmaceutical industry and certain medical device manufacturers.  The new law amends the existing California Integrated Waste Management Act and is expected to be a boom for medical waste disposal companies who stand to obtain significantly more business.  While the law was signed by the California Governor nearly two years ago, the regulations will go into effect in a few months (by January 1, 2021).  The original bill, dubbed the “California Sharps and Drug Takeback Bill”, requires a manufacturer of covered drugs or home-generated sharps waste, to offer safe disposal methods for their customers’ used and unused products.  The law has potentially sweeping affect because it encompasses all covered drugs and home generated sharps waste that are sold or offered for sale in California.

OSHA Fines Healthcare Facilities for Improper Use of N95 Respirators

Employers beware, particularly those in healthcare sectors.  If you provide a NIOSH-approved N95 “respirator” to protect employees from COVID-19, there are a number of OSHA respiratory protection standards that must be followed in a comprehensive Respiratory Protection Program.  The Department of Labor OSHA’s July 21, 2020, national press release makes clear that OSHA will seek the maximum possible penalties for serious violations against companies that do not fully satisfy the respiratory protection standards.

Re-Opening Medical Practices Following COVID-19 Outbreak

Over the last couple of weeks, a great deal has been written about the steps hospitals should take as they begin to provide elective procedures again as the COVID-19 outbreak slowly subsides in some parts of the US.  Lurking in the shadow of this issue is the question of what steps medical practices and outpatient clinics (“Medical Practices”) should take as they begin the process of returning to normal operations.

Retroactive Change in Distribution Methodology for Provider Relief Funds May Trigger Refunds

As I am sure you know, the U.S. Department of Health and Human Services (HHS) began distributing approximately $50 billion in Provider Relief Funds provided under the CARES Act between April 10 and April 17.  The initial distribution of Provider Relief Funds (consisting of approximately $30 billion) was distributed among healthcare providers based on their “proportionate share of Medicare fee-for-service reimbursement for 2019”.  For example, a provider with $15 million of Medicare FFS revenue in 2019 and $22 million in net patient revenue for 2018 would have received approximately $930,000 of Provider Relief Funds in the initial distribution:  ($15,000,000/$484,000,000,000 (Total Medicare FFS Revenue for 2019) x $30,000,000,000).

Is Your Hospital Ready to Re-Open for Elective Medical Services?

On April 19, 2020, the Centers for Medicare and Medicaid Services (“CMS”) provided its initial guidance to hospitals and other healthcare facilities (collectively, “Hospitals”) as they begin to consider the timing for re-commencing normal operations as the COVID-19 outbreak begins to subside in some parts of the United States (the “Re-Opening Recommendations”).[1]  In a sense, the Re-Opening Recommendations are the bookend to the guidance CMS provided on March 18, 2020 recommending that Hospitals discontinue the provision of non-emergent and elective medical services and treatments during the COVID-19 outbreak.[2]  In each case, the guidance provided by CMS is neither legally mandated nor enforceable.  Instead, the guidance merely provides a framework or frame of reference for use by Hospitals as they consider these decisions.

Public Health and Social Services Emergency Fund Payments

Many healthcare providers received an unanticipated cash infusion on or around April 10, 2020 (“Emergency Fund Payment”).  Accompanying the payments was a list of terms and conditions attached to the funds.  The U.S. Department of Health and Human Services (HHS) has stated that forms and additional information will be forthcoming; but in the meantime, the only available guidance is a letter to providers and the list of terms and conditions.

State Disaster Management Plans Impact Hospital Response to COVID-19 Outbreak

One of the most heavily-debated legal and ethical issues to arise during the current COVID-19 outbreak is what methodology a hospital should use to allocate ventilators when the number of patients who need a ventilator exceeds the hospital’s supply of ventilators.  Even more heavily discussed is whether a hospital should disconnect a patient from a ventilator against the wishes of the patient and his/her family in order to use that ventilator for another patient with a statistically greater chance of survival.

The CARES Act and Substance Use Disorder Records: Confidentiality Updates

Section 3221 of the CARES Act, signed into law on March 27, 2020, sets the stage for HHS to make significant changes to 42 C.F.R. Part 2, governing the confidentiality of Substance Use Disorder (“SUD”) records. Under the Act, HHS has 12 months to work with appropriate Federal agencies to make revisions to 42 C.F.R. Part 2 consistent with Section 3221’s mandates.

Prohibition on Beneficiary Inducements Hinders Rural Hospital Efforts to Aid Communities During COVID-19 Outbreak

During times of national or local crisis, people often look to the pillars of their communities, local employers, charities and other publicly-supported institutions, to provide much needed resources and stability.  In many rural communities, the local hospital fits into all three categories being one of the largest (if not they largest) local employer, charity and publicly-supported institution in the community (other than the local government).  As a result, people often look to hospitals during times of crisis, not just for healthcare services but also for the other resources needed in their lives (e.g., food, housing, financial assistance, etc.).

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